The Investigation of Underlying Mechanism of Lumbar Multifidus Muscle Activation Deficits

Low Back Pain Clinical Trial

Official title:

The Investigation of Underlying Mechanism of Lumbar Multifidus Muscle Activation Deficits in Adults With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05961774
• Other study ID #: MU-CIRB 2023/027.1503
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: June 14, 2024

Study information

• Verified date: June 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to investigate mechanism underlying lumbar multifidus muscle (LM) activation deficits in adults with chronic low back pain (CLBP). The main questions it aim to answer is whether motor cortex or muscular level is the underlying mechanism responsible for the LM activation deficits.

Participants will:

• Undergo cortical excitability measurement using transcranial magnetic stimulation, LM activation measurement using ultrasound imaging, and force measurement using hand-held dynamometer.

• Be randomly assigned to either repetitive magnetic stimulation (rTMS) or neuromuscular electrical stimulation (NMES)

• Undergo all measurement at post-intervention Researchers will compare within and between groups to see changes in cortical excitability, LM activation, and force.

Description:

Procedure The study will use a sample of convenience. The subject with CLBP will be recruited by the flyers posted at physical therapy clinic, as well as words of mouths. The participants who are interested in the study will undergo screening process for eligibility using the inclusion-exclusion criteria checklist. If the participants meet the eligibility criteria, participants will receive the brief information of the study and the consent process will be performed.

After receiving the informed consents, all participants will be requested to fill out the information sheet for demographic and clinical data. The participants will be asked to change the cloth of the top to be able to expose the lower back region. After collecting demographic and clinical data, 3-condition of LM thickness and cross-sectional area will be measured including 1) resting condition (Rest), maximum voluntary isometric contraction condition (MVIC), and maximum voluntary isometric contraction combined with neuromuscular electrical stimulation (COMB). The landmarks will be identified while the participants lay down in prone position. The landmarks include 1) lumbar spinous process of L2-L5 and 2) L4-5 facet joint (2 cm lateral to lower half of spinous process of L4). Rehabilitative ultrasound imaging (RUSI) will be used to measure LM activation and hand-held dynamometer will be used to measure force in this study across 3 conditions.

The participant will have 10 minutes rest before the transcranial magnetic stimulation (TMS). A pair of surface electrodes (Ag/AgCl, 10 mm) will be place according to SENIAM recommendation. The common ground electrode will be placed at the iliac crest. Two surface EMG electrodes will be placed relative to L4-5 along with the line joining from posterosuperior iliac spine and L1-L2 vertebral interspace (24) on the side of pain. The researcher will determine the hotspot of lumbar multifidus muscle area on the brain. The hotspot of the LM will be determined by least intensity of TMS which at least elicits 50 percent of measurable motor evoked potential (MEP) and this intensity will be the active motor threshold (AMT) of the participants. After the AMT is achieved, the 120% of AMT will be used as the intensity to induce the MEP. The MEP will be used to represent cortical excitability.

After the baseline RUSI and TMS data collection, the participants will be randomly assigned in to 2 groups include 1) NMES and high-frequency repetitive TMS (HF-rTMS) group. For HF-rTMS group, the participants will be in sitting position feet placed firmly on the floor. The stimulation point is the LM hot spot which is pre-determined by single pulse TMS as aforementioned. The HF-rTMS will be applied for participant individually. According to the theory, HF-rTMS results in facilitation of the targeted area; therefore, it will increase the excitability of the LM hot spot and potentially increase LM's neural drive and activation. The parameters will be set at frequency 10 Hz, 50 number of pulses, 40 train of stimulation (5 seconds stimulation and 25 seconds inter-stimulation interval) (34). The stimulation will approximately 20 minutes. The position of coil will be placed tangentially at 45 degrees on the LM hotspot. For the neuromuscular electrical stimulation (NMES) group, participants will be lying in prone position. The landmarks and electrodes placements are the same as mentioned in MVIC combined with NMES and LM thickness measurement. NMES parameters are interferential current 6000 Hz, amplitude 20-50 Hz with scanning mode, duration 20-minute, intensity to elicit the LM contraction (6). After the participants completed receiving the stimulation, the participant will undergo the collecting the LM thickness and force again using the same protocol.

Data will be used to 1) identify changes in cortical excitability, LM activation and force before and after stimulation at cortical level by HF-rTMS, 2) identify changes in cortical excitability, LM activation and force before and after stimulation at muscular level by NMES, and 3) compare the percent changes in cortical excitability, LM activation and force between stimulation at cortical (by HF-rTMS) and muscular (by NMES) levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male and female age between 18 and 40 years.

• Experience of low back pain at least 3 months, or recurrent of back pain for at least two episodes in 6 months that interferes with activities of daily living.

Exclusion Criteria:

• Spondylolysis, spondylolisthesis, spine tumor and malignancy

• Radiculopathy or myelopathy

• History of lumbar or abdominal surgery

• Pregnancy

• Neurological Disease (e.g., stroke, Parkinson, traumatic brain injury, spinal cord injury)

• Major cardiovascular diseases (e.g., heart failure, coronary artery diseases, angina pain)

• Skin lesion (e.g., skin laceration) on site of stimulation.

• Experience of lumbar motor control exercise more than or equal to 2 weeks

• Metal implantation sensitive to magnetic field, or cardiac implantations

• BMI greater or equal to 30 kg/m2

• Taking any medications that would interfere with brain stimulation (e.g., Calcium channel blockers, Na+ channel blocker, NMDA antagonist, Glutamate receptor antagonist, nicotine uptake)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Transcranial magnetic stimulation
The stimulation point is the lumbar multifidus hotspot. The parameters will be set at frequency 10 Hz, 50 number of pulses, 40 train of stimulation (5 seconds stimulation and 25 seconds inter-stimulation interval). The position of coil will be placed tangentially at 45 degrees on the LM hotspot. The stimulation will be 20 minutes.
• Neuromuscular electrical stimulation
The neuromuscular electrical stimulation will be set as interferential current 6000 Hz, amplitude 20-50 Hz with scanning mode, duration 20 minutes, intensity to elicit the LM contraction.

Locations

Country	Name	City	State
Thailand	Faculty of Physical Therapy, Mahidol University	Salaya	Nakhon Pathom

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (12)

Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827. — View Citation

Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. Corticomotor control of lumbar multifidus muscles is impaired in chronic low back pain: concurrent evidence from ultrasound imaging and double-pulse transcranial magnetic stimulation. Exp Brain Res. 2016 Apr;234(4):1033-45. doi: 10.1007/s00221-015-4528-x. Epub 2015 Dec 26. — View Citation

Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. The side of chronic low back pain matters: evidence from the primary motor cortex excitability and the postural adjustments of multifidi muscles. Exp Brain Res. 2017 Mar;235(3):647-659. doi: 10.1007/s00221-016-4834-y. Epub 2016 Nov 15. — View Citation

O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014 Apr 11;(4):CD008208. doi: 10.1002/14651858.CD008208.pub3. — View Citation

Patricio P, Roy JS, Macedo L, Roy M, Leonard G, Hodges P, Masse-Alarie H. Repetitive transcranial magnetic stimulation alone and in combination with motor control exercise for the treatment of individuals with chronic non-specific low back pain (ExTraStim trial): study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 24;11(3):e045504. doi: 10.1136/bmjopen-2020-045504. — View Citation

Songjaroen S, Sungnak P, Piriyaprasarth P, Wang HK, Laskin JJ, Wattananon P. Combined neuromuscular electrical stimulation with motor control exercise can improve lumbar multifidus activation in individuals with recurrent low back pain. Sci Rep. 2021 Jul 20;11(1):14815. doi: 10.1038/s41598-021-94402-2. — View Citation

Strutton PH, Theodorou S, Catley M, McGregor AH, Davey NJ. Corticospinal excitability in patients with chronic low back pain. J Spinal Disord Tech. 2005 Oct;18(5):420-4. doi: 10.1097/01.bsd.0000169063.84628.fe. — View Citation

Tsao H, Danneels LA, Hodges PW. ISSLS prize winner: Smudging the motor brain in young adults with recurrent low back pain. Spine (Phila Pa 1976). 2011 Oct 1;36(21):1721-7. doi: 10.1097/BRS.0b013e31821c4267. — View Citation

van Dieen JH, Reeves NP, Kawchuk G, van Dillen LR, Hodges PW. Motor Control Changes in Low Back Pain: Divergence in Presentations and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):370-379. doi: 10.2519/jospt.2019.7917. Epub 2018 Jun 12. — View Citation

Wallwork TL, Stanton WR, Freke M, Hides JA. The effect of chronic low back pain on size and contraction of the lumbar multifidus muscle. Man Ther. 2009 Oct;14(5):496-500. doi: 10.1016/j.math.2008.09.006. Epub 2008 Nov 21. — View Citation

Wand BM, Parkitny L, O'Connell NE, Luomajoki H, McAuley JH, Thacker M, Moseley GL. Cortical changes in chronic low back pain: current state of the art and implications for clinical practice. Man Ther. 2011 Feb;16(1):15-20. doi: 10.1016/j.math.2010.06.008. Epub 2010 Jul 23. — View Citation

Wattananon P, Sungnak P, Songjaroen S, Kantha P, Hsu WL, Wang HK. Using neuromuscular electrical stimulation in conjunction with ultrasound imaging technique to investigate lumbar multifidus muscle activation deficit. Musculoskelet Sci Pract. 2020 Dec;50:102215. doi: 10.1016/j.msksp.2020.102215. Epub 2020 Jul 13. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting motor threshold	The stimulus intensity that causes a minimum motor response in a resting muscle during single transcranial magnetic stimulation (TMS) pulses applied over the motor hotspot.	Change from baseline after 1 session
Primary	Active motor threshold	The lowest stimulus intensity to elicit a motor evoked potential = 200µV in 5 out of 10 consecutive trials during an isometric contraction of 10% maximum voluntary contraction in the target muscle.	Change from baseline after 1 session
Primary	Motor evoked potential	The electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.	Change from baseline after 1 session
Primary	Cortical silent period	The temporary interruption of electromyographic signal from a muscle following a motor evoked potential triggered by transcranial magnetic stimulation over the primary motor cortex.	Change from baseline after 1 session
Primary	Muscle thickness	Muscle contractility.	Change from baseline after 1 session
Primary	Muscle cross-sectional area	Cross-sectional area can be related to joint torque production and isokinetic strength in different muscle groups.	Change from baseline after 1 session
Primary	Muscle pennation angle	Pennation angle can represent the maximum force developed by a muscle	Change from baseline after 1 session
Secondary	Force generation	Hand-held dynamometer will be used to measure muscle force.	Change from baseline after 1 session